FDA — authorised 25 July 2000
- Status: approved
🇺🇸 Abreva in United States
FDA authorised Abreva on 25 July 2000
Marketing authorisations
FDA — authorised 19 November 2018
- Application: ANDA208754
- Marketing authorisation holder: P AND L
- Local brand name: DOCOSANOL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 3 May 2022
- Application: ANDA215839
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 7 October 2022
- Application: ANDA212385
- Marketing authorisation holder: P AND L DEVELOPMENT
- Local brand name: DOCOSANOL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 October 2023
- Application: ANDA214454
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: DOCOSANOL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 1 March 2024
- Application: ANDA217090
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 14 April 2026
- Application: NDA020941
- Marketing authorisation holder: HALEON US HOLDINGS
- Indication: Labeling
- Status: approved
The FDA approved Abreva, a product of HALEON US HOLDINGS, for its labeling indication on April 14, 2026. The approval was granted through the standard expedited pathway. Abreva is a medication that will be marketed in the United States.
Abreva in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Dermatology approved in United States
Frequently asked questions
Is Abreva approved in United States?
Yes. FDA authorised it on 25 July 2000; FDA authorised it on 19 November 2018; FDA authorised it on 3 May 2022.
Who is the marketing authorisation holder for Abreva in United States?
Marketing authorisation holder not available in our data.